Systems Engineer (Electromechanical Medical Devices) at Engenious Design

Job description

We’re seeking an experienced product development Systems Engineer who can think big-picture while staying hands-on across diverse technologies. You’ll define user needs, drive system‑level requirements, and unite electrical, mechanical, and software disciplines into cohesive products. Acting as the connective tissue across designers, engineers, and clients, you’ll navigate tradeoffs, manage risk, and tackle complex integration challenges to deliver life‑changing medical and high‑tech products. What You’ll Do: • Maintain the System View: Act as the holistic thinker for the product—maintaining a clear mental model of the system, identifying roadblocks early, and guide the team toward effective solutions. • Lead Cross-Functional Integration: Coordinate electrical, mechanical, software, industrial design, and test workstreams to ensure the product functions as a cohesive system. • Drive Requirements & Traceability: Lead the definition of user needs and product requirements, maintaining clear traceability from requirements to design decisions, risk management, and verification. • Own Risk Management: Proactively identify, prioritize, document, and manage technical and program risks, working closely with the design team to develop and execute mitigation strategies. • Act as a Technical Investigator: Use prototypes, proof-of-concept builds, and engineering testing to validate concepts and inform design direction. • Enable Informed Decisions: Communicate system architecture, progress, risks, and tradeoffs clearly to teams and clients, empowering confident design decisions. • Guide Compliance & Documentation: Ensure development follows the governing QMS and regulatory standards while maintaining a right-sized Design Development File. Position Details: This is a full-time, permanent position. This leadership position is based in our Kansas City design center, and not available as a remote job. Qualifications: • 5+ years of applicable experience in electromechanical/embedded system product development • Degree in a relevant engineering background (e.g Biomedical, Mechanical, Electrical, Software), or equivalent experience. • Experience interpreting and applying medical device standards such as IEC 60601-1, ISO 13485 etc. Nice to haves: • Experience leading cross-functional teams of engineers and designers While we recognize that top talent comes from all over the world, we are a small team and are not able to offer visa sponsorship at this time. Candidates must be authorized to work in the United States without requiring visa sponsorship

Requirements

Must-haves

What You’ll Do: • Maintain the System View: Act as the holistic thinker for the product—maintaining a clear mental model of the system, identifying roadblocks early, and guide the team toward effective solutions.
Lead Cross-Functional Integration: Coordinate electrical, mechanical, software, industrial design, and test workstreams to ensure the product functions as a cohesive system.
Drive Requirements & Traceability: Lead the definition of user needs and product requirements, maintaining clear traceability from requirements to design decisions, risk management, and verification.
Own Risk Management: Proactively identify, prioritize, document, and manage technical and program risks, working closely with the design team to develop and execute mitigation strategies.
Act as a Technical Investigator: Use prototypes, proof-of-concept builds, and engineering testing to validate concepts and inform design direction.
Enable Informed Decisions: Communicate system architecture, progress, risks, and tradeoffs clearly to teams and clients, empowering confident design decisions.
Guide Compliance & Documentation: Ensure development follows the governing QMS and regulatory standards while maintaining a right-sized Design Development File.
This is a full-time, permanent position. This leadership position is based in our Kansas City design center, and not available as a remote job.
Qualifications: • 5+ years of applicable experience in electromechanical/embedded system product development
Degree in a relevant engineering background (e.g Biomedical, Mechanical, Electrical, Software), or equivalent experience.
Experience interpreting and applying medical device standards such as IEC 60601-1, ISO 13485 etc.

Nice-to-haves

Nice to haves: • Experience leading cross-functional teams of engineers and designers

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: jazzhr
Effort: medium